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| ID | Type | Description | Link |
|---|---|---|---|
| IRB number 23-0460 | Other Identifier | UPenn |
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| Name | Class |
|---|---|
| Blue Cross Blue Shield | OTHER |
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The proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
The proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG delivery at home | Other | The BCG at home project will be a single-arm prospective pilot, to evaluate the feasibility, scalability and effectiveness of home treatment, and utilize the BB-Bot (chatbot) for PRO and adverse event measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adherence to BCG therapy at 3 months after study initiation | The primary outcome will be the rate of adherence to AUA guidelines for BCG therapy as measured by successful treatments of BCG compared to expected treatments. For each participant, adherence will be calculated both as the percentage of adherent doses, evaluable for study participants | 3 months after study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| • Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation | The secondary outcomes will include self-efficacy and symptom management. | 3 months after study initiation |
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Inclusion Criteria:
Inclusion criteria for patients in Cohort 1
Cohort 2 inclusion criteria
Exclusion Criteria:
Cohort 1 exclusion criteria
• inability to provide informed consent
Cohort 2 exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Lee, PI, MD | Contact | 215-615-3780 | daniel.lee4@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |